BEECHAMS MULTI-SYMPTOM RELIEF

Adults and children 16 years and over One 20 ml measured dose (or four 5 ml spoonfuls). Repeat every four hours as necessary. Do not exceed four doses per 24 hours. Not to be given to children under 16 years except on medical advice. Elderly The normal adult dose may be taken.

Do not take continuously for more than 5 days without medical advice

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. ** There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Undesirable effect Psychiatric disorders Nervousness, i r r i t a b i l i t y , r e s t l e s s n e s s , a n d excitability Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, Vomiting, diarrhoea Adverse reactions identified during post-marketing use are listed below.

The frequency of these reactions is unknown but likely to be rare. g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions including cross- sensitivity with other sympathomimetics may occur. Renal and urinary disorders Dysuria, urinary retention.

This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Guaifenesin The frequency of these events is unknown but considered likely to be rare. Body system Undesirable effect Immune system disorders Allergic reactions, angioedema, anaphylactic reactions Respiratory, thoracic and mediastinal disorders Dyspnoea* Gastrointestinal disorders Nausea, vomiting, abdominal discomfort, Skin and subcutaneous disorders Rash, urticaria

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Patients suffering from chronic cough or asthma should consult a physician before taking this product.

Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache. Do not take with a cough suppressant. g. Raynaud’s Phenomenon) Cardiovascular disease This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) The amount of alcohol should be taken into account in children and high-risk groups.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. Concomitant use of other paracetamol-containing products should be avoided.

If symptoms persist consult your doctor. Special label warnings Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Contains ethanol, glycerol, sorbitol and Sunset Yellow, see leaflet for further information. Special leaflet warnings Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

e. 6 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high- risk groups such as patients with liver disease, or epilepsy. Glycerol may cause headache, stomach upset and diarrhoea.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. 175 g fructose. Sunset Yellow (E110) may cause allergic reactions.

Hypersensitivity to paracetamol and/or other constituents. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. 5).